Vaccine Manufacturing Process Engineer, Purification (req1991)

Company: Frederick National Laboratory
Location: Frederick
Posted on: July 20, 2021

Job Description:

PROGRAM DESCRIPTION

The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its' mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g. HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.

KEY ROLES/RESPONSIBILITIES

The Vaccine Manufacturing Process Engineer will serve as a Point of Contact (POC) for QA, regarding quality issues related to the Purification group to include:

• Initiate, facilitate progress, and closure of change controls
• Investigation of root cause, evaluation of product impact, and facilitate closure of deviations
• Initiate, lead cross-functional team discussions, and completion of final report for risk assessments
• Open, facilitate implementation, and facilitate closure of Preventive Actions (PA)
• Open, facilitate implementation, and facilitate closure of Corrective Actions (CA)
• Open, investigate, determine root cause, propose corrective/preventive actions for potential improvements, and facilitate closure of investigations
• Serve as technical oversite during execution of the Purification production runs
• Ensure process is performed as technology transfer (TT) process intended
• Advise operators/Supervisor during unexpected or adverse outcomes
• Act as on-the-floor client liaison when client is on site observing operations
• Participate in bioprocessing scale-up, technology transfer, and execution of Downstream processes
• Troubleshoot problems where analysis of situations and of data requires in-depth evaluation of various factors
• Author and revise documents (MBR's and SOP's) for downstream processes and equipment
• Provide process and equipment training for manufacturing associates
• Provide support for QA and Regulatory for investigations and audits
• Review documents for regulatory submissions when required
• Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining solutions
• Support FAT, SAT and validation activities
• Evaluate new technology and provide suggestions for improvement of manufacturing process
• Will work directly with government process development scientists in the performance of assigned duties and will be responsible for ongoing communications to working groups and project teams

• Possession of Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
• In addition to education requirement, a minimum of five (5) years of progressively responsible job-related experience with progressively responsible job-related experience in a pharmaceutical cGMP environment
• Experience in working and troubleshooting of manufacturing equipment
• Hands-on experience in downstream purification processes and prior experience in process scale-up and tech-transfer
• Some experience in leading cross-functional and departmental meetings
• Ability to obtain and maintain a security clearance

• Master's degree in biochemical engineering or related field is desired
• Engineering analysis of bioprocessing methods; may include a specialty in downstream purification (e.g., filtration, ultrafiltration, chromatography separations, system programming) or bioreactor cell culture/fermentation (e.g., cell expansion, bioreactor control and analysis, centrifugation and depth filtration for clarification)
• Experience using TrackWise quality record management software
• Experience using Unicorn software for operation of Cytiva (formerly GE) process equipment

• This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations

Keywords: Frederick National Laboratory, Frederick , Vaccine Manufacturing Process Engineer, Purification (req1991), Other , Frederick, Maryland